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Lixisenatide in Acute Coronary Syndrome) trial, the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial, the SUSTAIN 6 (Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes) trial, the EXSCEL (Exenatide Study of Cardiovascular Event Lowering) trial, the HARMONY Outcomes (Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus) trial, the REWIND (Researching Cardiovascular Events With a Weekly Incretin in Diabetes) trial, the PIONEER 6 (Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes) trial, and the AMPLITUDE-O (Effect of Efpeglenatide on Cardiovascular Outcomes) trial (Supplementary data online, Table S8).70,72,158–163 Five of the eight GLP-1 RAs tested demonstrated superior CV outcomes on the primary composite of time to the first event of CV death, 0.5 1 1.5 Favours GLP-1RA Favours Placebo GLP-1 receptor agonist n/N (%) Placebo n/N (%) Hazard ratio (95% CI) NNT (95% CI) 0.87 (0.78–0.97) 0.74 (0.58–0.95) 0.91 (0.83–1.00) 0.78 (0.68–0.90) 0.88 (0.79–0.99) Subtotal (I2 = 14.9%, P = 0.316) 0.79 (0.57–1.11) 0.73 (0.58–0.92) 0.85 (0.80–0.90) 61 (46–92) P value 0.01 0.016 0.061 0.0006 0.026 0.17 0.0069 <0.0001 Three-point MACE 0.78 (0.66–0.93) 0.98 (0.65–1.48) 0.88 (0.76–1.02) 0.93 (0.73–1.19) 0.91 (0.78–1.06) Subtotal (I2 = 12.4%, P = 0.335) 0.49 (0.27–0.92) 0.72 (0.50–1.03) 0.85 (0.78–0.93) 142 (97–305) 0.007 0.92 0.096 0.58 0.21 0.021 0.07 0.0005 Cardiovascular death 0.86 (0.73–1.00) 0.81 (0.57–1.16) 0.97 (0.85–1.10) 0.75 (0.61–0.90) 0.96 (0.79–1.15) Subtotal (I2 = 16.2%, P = 0.306) 1.04 (0.66–1.66) 0.75 (0.54–1.05) 0.88 (0.81–0.96) 154 (97–463) 0.046 0.26 0.62 0.003 0.63 0.49 0.09 0.0048 Fatal or non-fatal myocardial infarction 0.86 (0.71–1.06) 0.65 (0.41–1.03) 0.85 (0.70–1.03) 0.86 (0.66–1.14) 0.76 (0.62–0.94) Subtotal (I2 = 0.0%, P = 0.903) Note: Weights are from random effects analysis LEADER SUSTAIN-6 EXSCEL Harmony Outcomes REWIND PIONEER 6 AMPLITUDE-O LEADER SUSTAIN-6 EXSCEL Harmony Outcomes REWIND PIONEER 6 AMPLITUDE-O LEADER SUSTAIN-6 EXSCEL Harmony Outcomes REWIND PIONEER 6 AMPLITUDE-O LEADER SUSTAIN-6 EXSCEL Harmony Outcomes REWIND PIONEER 6 AMPLITUDE-O 0.76 (0.37–1.56) 0.74 (0.47–1.17) 0.81 (0.74–0.90) 171 (124–324) 0.16 0.066 0.095 0.30 0.010 0.43 0.19 <0.0001 Fatal or non-fatal stroke TRIAL 608/ 108/ 839/ 338/ 594/ 694/ 146/ 905/ 428/ 663/ 61/ 189/ 76/ 125/ 219/ 44/ 340/ 122/ 317/ 278/ 46/ 383/ 130/ 346/ 15/ 75/ 30/ 50/ 292/ 54/ 483/ 181/ 223/ 339/ 67/ 493/ 240/ 231/ 37/ 91/ 35/ 58/ 173/ 30/ 187/ 94/ 158/ 199/ 46/ 218/ 108/ 205/ 13/ 47/ 17/ 31/ 4668 1648 7356 4731 4949 4672 1649 7396 4732 4952 1591 2717 1592 1359 4668 1648 7356 4731 4949 4672 1649 7396 4732 4952 1591 2717 1592 1359 4668 1648 7356 4731 4949 4672 1649 7396 4732 4952 1591 2717 1592 1359 4668 1648 7356 4731 4949 4672 1649 7396 4732 4952 1591 2717 1592 1359 (13%) (7%) (11%) (7%) (12%) (15%) (9%) (12%) (9%) (13%) (4%) (7%) (5%) (9%) (5%) (3%) (5%) (3%) (6%) (6%) (3%) (5%) (3%) (7%) (1%) (3%) (2%) (4%) (6%) (3%) (7%) (4%) (5%) (7%) (4%) (7%) (5%) (5%) (2%) (3%) (2%) (4%) (4%) (2%) (3%) (2%) (3%) (4%) (3%) (3%) (2%) (4%) (1%) (2%) (1%) (2%) Figure 6 Meta-analysis of cardiovascular outcomes trials with glucagon-like peptide-1 receptor agonists (sensitivity analysis removing ELIXA). Risk of major adverse cardiovascular events and its components. CI, confidence interval; GLP-1, glucagon-like peptide-1; MACE, major adverse cardiovascular outcomes; NNT, number needed to treat. Figure adapted from Sattar et al. 2021.Reprinted from the Lancet with permission from Elsevier.164 ESC Guidelines 4067 Downloaded from academic.oup.com/eurheartj/article/44/39/4043/7238227 by guest on 07 October 2026